AliveDx Suisse SA

AliveDx Suisse SA produces in vitro diagnostic (IVD) reagents and quality controls specifically designed for blood bank testing and allergen-specific IgE assays. Their product line includes automated immunoassay reagents like the MosaiQ® AiPlex VAS and MosaiQ® AiPlex CD, as well as individual components such as detection reagents, conjugates, substrates, and sample diluents. These devices are intended for use in automated testing workflows, particularly in immunoassay platforms.

AliveDx Suisse SA is headquartered in Switzerland, which is within the European Economic Area (EEA). Since their devices fall under the EU In Vitro Diagnostic Regulation (IVDR), the company must comply with EEA regulatory requirements. Being based in Switzerland allows them to leverage the EU’s regulatory framework while ensuring their products meet the necessary standards for market placement in the EU.

AliveDx Suisse SA’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. This registration is required under the IVDR to ensure transparency and traceability of devices placed on the EU market. EUDAMED helps regulatory authorities and stakeholders verify compliance and device details.

AliveDx Suisse SA’s devices are classified as Class A and Class B in vitro diagnostics under the EU IVDR. Classification depends on factors like the intended use, potential risks, and patient impact. Class A devices pose minimal risk (e.g., simple reagents), while Class B devices involve moderate risk (e.g., automated immunoassay systems). This classification determines the regulatory requirements for their design, manufacturing, and post-market surveillance.